A Prospective Randomized Controlled Clinical Trial of Restrictive Versus Liberal Perioperative Fluid Management for Patients Undergoing Pancreatic Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 331
- 试验地点
- 1
- 主要终点
- To determine if restrictive perioperative fluid management results in fewer complications, morbidity and decreased length of stay in patients undergoing pancreatic resection, compared to liberal fluid management.
研究概览
简要总结
The purpose of this study is to help us learn what the best amount of fluid is that patients should receive during pancreas surgery. Patients will receive either the liberal fluid amount for this surgery or a restricted fluid amount.
Both amounts of fluid have been used safely in patients having similar surgeries. These amounts have not been compared in pancreatic surgery. The fluids regimens that will be given are not experimental.
This study will compare patients in the liberal and restricted fluid groups in terms of the nature of any surgical complications (problems)and recovery from surgery, including length of hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults > or = 18 years
- •Patients scheduled for Pancreaticoduodenectomy, Central Pancreatectomy or Distal Pancreatectomy.
排除标准
- •Pregnancy
- •History of active coronary disease unless a cardiac stress test showing no reversible ischemia and normal LV function within 30 days of operation
- •MI within 3 months
- •History of stroke
- •History of congestive heart failure and ejection fraction less than 35%
- •History of severe COPD and resting oxygen saturation (SpO2) < 90%
- •Renal dysfunction (Cr > 1.8)
- •Abnormal coagulation parameters (INR > 1.5 not on Coumadin, or platelet
- •Presence of active infection including HIV
- •BMI > 35
- •American Society of Anesthesiologists Status > III, assigned at time of preoperative visit
- •Corticosteroid use > 10 mg Prednisone/day
- •Bilirubin > 10.0
结局指标
主要结局
To determine if restrictive perioperative fluid management results in fewer complications, morbidity and decreased length of stay in patients undergoing pancreatic resection, compared to liberal fluid management.
时间窗: 3 years
次要结局
- Determine if restrictive perioperative fluid management, comp to liberal periop fluid management, decreases delayed gastric emptying, length of stay (LOS) & the incidence of other, less frequent morbidity in adult patients getting pancreatic resection.(3 years)